Metastatic Breast CancerNCT05964504
Improving Survival for Metastatic Lobular Breast Cancer (PLUMB Registry)
An observational study of Metastatic Breast Cancer and Lobular Breast Carcinoma, run by University of California, San Francisco at 4 sites in United States.
Trial summary
This is a prospective observational registry for patients with invasive lobular carcinoma (ILC) of the breast. After the first 1cohort is enrolled, the collected data will be utilized to develop an ILC specific response assessment tool. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer, Lobular Breast Carcinoma
- What is being tested?
- Blood Specimen
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 4 sitesUnited States
- Study dates
- 20 Dec 2023to 28 Feb 2036
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult participants with histologically proven stage IV invasive lobular carcinoma
Who may be able to join
- Histologically confirmed invasive lobular carcinoma. Mixed lobular/ductal cancer is allowed.
- Age >=18 years
- Any receptor subtype.
- Ability to understand a written informed consent document, and the willingness to sign it.
Who cannot join
- Stage I-III breast cancer.
- Lack of lobular histology on tumor biopsy.
- Other active cancer (prior treated cancer with no current evidence of disease is allowed).
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Jason Mouabbi, MD
- Recruiting
Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
Rachel Jankowitz, MD
- Recruiting
University of California, San Diego
San Diego, California, 92053
Rebecca Shatsky, MD
- Recruiting
University of California, San Francisco
San Francisco, California, 94122
Venezia Garza, 415-353-8732, venezia.garza@ucsf.edu
Rita Mukhtar, MD
About this study
Official title: Improving Survival for Those With Metastatic Lobular Breast Cancer Through Development of the Multi-center PLUMB Registry-a Prospective Study of LobUlar Metastatic Breast Cancer
This is a prospective observational registry for patients with invasive lobular carcinoma (ILC) of the breast. After the first 1cohort is enrolled, the collected data will be utilized to develop an ILC specific response assessment tool.
Read the detailed description
Primary Aims:
- To evaluate the feasibility of developing a histologic based registry for participants living with metastatic lobular breast cancer.
- To understand the natural history, treatment patterns, and overall survival in patients with metastatic ILC using modern, real-world data.
Secondary Aims:
- To evaluate the correlation between imaging findings and disease progression.
- To evaluate the correlation between ctDNA and disease progression.
- To develop an ongoing platform for evaluating new imaging tools, tumor markers, and participant recruitment for clinical trials.
Outline:
Participants will be recruited to participate in the registry during a regularly scheduled clinic visit with their treating oncologist, and consented to participate at this time. At each evaluation time point, participants will have a blood draw performed. Participants will be followed until loss to follow up, death, or withdrawal from the registry.
- Conditions
- Metastatic Breast Cancer, Lobular Breast Carcinoma
- Being tested
- Blood Specimen
- Medical subject headings
- Breast Neoplasms, Carcinoma, Lobular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood SpecimenProcedure or surgery
Blood will be drawn via venipuncture
| Study group | Role | What they receive |
|---|---|---|
| Initial Cohort | Up to 12 participants at each evaluation timepoint (approximately every 3-6 months to follow standard of care visits) will have up to 40 mL of blood drawn and distributed into 8 cell-free DNA Streck tubes for plasma isolation, cell-free DNA extraction, and ctDNA analysis. Blood for ctDNA analysis will be collected within ±14 days of whole-body imaging studies, which will occur when patients are scheduled for standard of care whole-body imaging. Receives: Procedure: Blood Specimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of registry
Feasibility is defined as enrollment of 10-12 patients with metastatic ILC in the first 2 years across all participating sites, and collection of clinical assessments in >=75% of treating medical oncologists
Measured: Up to 2 years
Proportion of patients with measurable versus unmeasurable disease
Proportion of patients with measurable disease versus unmeasurable disease using Response Evaluation Criteria in Solid Tumors (RECIST) will be reported for each line of treatment as determined by their oncologist.
Measured: Up to 10 years
Median Progression Free Survival Rate
The median Progression-free survival rate (PFS) for participants enrolled in the registry will be utilized to develop the ILC specific response assessment tool.
Measured: Up to 10 years
Median Overall Survival Rates
The overall rate of survival for participants enrolled in the registry will be utilized to develop the ILC specific response assessment tool.
Measured: Up to 10 years
Secondary outcomes (5)
Proportion of participants who are currently taking estrogen receptor modulators or degraders
The overall proportion of participants who are currently taking estrogen receptor modulators or degraders which may interfere with a radiolabeled form of estradiol (FES) in a positron Emission Tomography (PET) versus the participants medical oncologist assessment of disease progression will be utilized to develop the ILC specific response assessment tool.
Measured: Up to 10 years
Mean Change in Circulating tumor DNA (ctDNA)
The overall change in quantity of ctDNA mean tumor molecules per mL blood versus medical oncologist assessment of disease progression will be utilized to develop the ILC specific response assessment tool.
Measured: Up to 10 years
Number of novel imaging tools
The number of novel imaging tools developed during the course of data collection to improve the determination of disease status will be utilized to develop the ILC specific response assessment tool.
Measured: Up to 10 years
Number of new tumor markers introduced
The number of participants who have detectable mutations on ctDNA evaluations with are correlated with health outcomes will be utilized to develop the ILC specific response assessment tool.
Measured: Up to 10 years
Number of participants enrolled in clinical trials
The number of participants with metastatic ILC who have enrolled on a clinical trial will be utilized to develop the ILC specific response assessment tool.
Measured: Up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start20 Dec 2023
- Primary completion28 Feb 2036 (estimated)
- Study completion28 Feb 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- METAvivor Research and Support, Inc
- Responsible party
- Sponsor
- Investigators
- Rita Mukhtar, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05964504
- Sponsor's protocol ID
- 237513
- Other IDs
- NCI-2026-05557
- Status last verified
- Nov 2026
- First submitted
- 19 Jul 2023
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Survival for Those With Metastatic Lobular Breast Cancer Through Development of the Multi-center PLUMB Registry-a Prospective Study of LobUlar Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT05964504
- Acronym / sponsor ID
- 237513
- Conditions
- Metastatic Breast Cancer, Lobular Breast Carcinoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- METAvivor Research and Support, Inc
- Study start
- 20 Dec 2023 (actual)
- Primary completion
- 28 Feb 2036 (estimated)
- Study completion
- 28 Feb 2036 (estimated)
- First posted
- 28 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective observational registry for patients with invasive lobular carcinoma (ILC) of the breast. After the first 1cohort is enrolled, the collected data will be utilized to develop an ILC specific response assessment tool.
Detailed description
Primary Aims:
- To evaluate the feasibility of developing a histologic based registry for participants living with metastatic lobular breast cancer.
- To understand the natural history, treatment patterns, and overall survival in patients with metastatic ILC using modern, real-world data.
Secondary Aims:
- To evaluate the correlation between imaging findings and disease progression.
- To evaluate the correlation between ctDNA and disease progression.
- To develop an ongoing platform for evaluating new imaging tools, tumor markers, and participant recruitment for clinical trials.
Outline:
Participants will be recruited to participate in the registry during a regularly scheduled clinic visit with their treating oncologist, and consented to participate at this time. At each evaluation time point, participants will have a blood draw performed. Participants will be followed until loss to follow up, death, or withdrawal from the registry.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Initial Cohort | – | Procedure: Blood SpecimenUp to 12 participants at each evaluation timepoint (approximately every 3-6 months to follow standard of care visits) will have up to 40 mL of blood drawn and distributed into 8 cell-free DNA Streck tubes for plasma isolation, cell-free DNA extraction, and ctDNA analysis. Blood for ctDNA analysis will be collected within ±14 days of whole-body imaging studies, which will occur when patients are scheduled for standard of care whole-body imaging. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult participants with histologically proven stage IV invasive lobular carcinoma
Key inclusion criteria (4 listed)
- Histologically confirmed invasive lobular carcinoma. Mixed lobular/ductal cancer is allowed.
- Age >=18 years
- Any receptor subtype.
- Ability to understand a written informed consent document, and the willingness to sign it.
Key exclusion criteria (3 listed)
- Stage I-III breast cancer.
- Lack of lobular histology on tumor biopsy.
- Other active cancer (prior treated cancer with no current evidence of disease is allowed).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood SpecimenBlood will be drawn via venipuncture | Procedure or surgery | Initial Cohort |
Primary outcome
Feasibility of registry
Time frame: Up to 2 years
Feasibility is defined as enrollment of 10-12 patients with metastatic ILC in the first 2 years across all participating sites, and collection of clinical assessments in >=75% of treating medical oncologists
Proportion of patients with measurable versus unmeasurable disease
Time frame: Up to 10 years
Proportion of patients with measurable disease versus unmeasurable disease using Response Evaluation Criteria in Solid Tumors (RECIST) will be reported for each line of treatment as determined by their oncologist.
Median Progression Free Survival Rate
Time frame: Up to 10 years
The median Progression-free survival rate (PFS) for participants enrolled in the registry will be utilized to develop the ILC specific response assessment tool.
Median Overall Survival Rates
Time frame: Up to 10 years
The overall rate of survival for participants enrolled in the registry will be utilized to develop the ILC specific response assessment tool.
5 secondary outcomes
Proportion of participants who are currently taking estrogen receptor modulators or degraders
Time frame: Up to 10 years
Mean Change in Circulating tumor DNA (ctDNA)
Time frame: Up to 10 years
Number of novel imaging tools
Time frame: Up to 10 years
Number of new tumor markers introduced
Time frame: Up to 10 years
Number of participants enrolled in clinical trials
Time frame: Up to 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rita Mukhtar, MD principal investigator
University of California, San Francisco
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Breast Cancer and Lobular Breast Carcinoma, run by University of California, San Francisco at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Venezia Garza (415-353-8732, venezia.garza@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of registry (time frame: Up to 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.